Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma

Inclusion criteria

• Patients must have histologically confirmed esophageal squamous cell carcinoma with relapse disease and the primary tumor have been surgically removed.

• With measurable or evaluable disease defined by RECIST 1.1 criteria by multi-slice spiral CT or MRI scan.
• - Failed in or disease progressed after fist-line chemotherapy (If failed in perioperative chemotherapy or disease progressed in 24 weeks after perioperative chemotherapy, the perioperative chemotherapy is regard as first-line chemotherapy )
• - Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
• - Without serious system dysfunction and could tolerate chemotherapy.
• - With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a neutrophil count of ≥2.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
• - Life expectancy ≥3 months
• - With normal electrocardiogram results and no history of congestive heart failure.
• - Without bleeding and thrombosis disease
• - With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN
• - Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug
• - With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
• - With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion criteria

• Patients who have received irinotecan or apatinib in previous treatment.
• Primary tumor is not resected.
• Uncontrolled hypertension (after treatment with antihypertensive drugs cannot reduced to the normal range: systolic pressure <140 mmHg and diastolic pressure <90 mmHg)
• With ≥ grade 2 coronary heart disease, arrhythmia (including corrected QT interval prolongation male >450 ms, women >470 ms)
• Cannot take oral tables including uncontrolled vomiting, chronic diarrhea and intestinal obstruction.
• With potential bleeding risk including (1) peptic ulcer and fecal occult blood (++); (2) melena or hematemesis history in last 3 months; (3) fecal occult blood (+) or (+/-) and endoscopy showed ulcer or other diseases with bleeding risk.
• With abnormal coagulation function (INR>1.5 ULN, APTT>1.5 ULN),
• With thrombosis or receiving anticoagulant treatment.
• With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
• With brain metastasis of tumor
• Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment).